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Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Sponsor: Loxo Oncology, Inc.
Summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Official title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2021-03-09
Completion Date
2027-05
Last Updated
2025-04-20
Healthy Volunteers
No
Interventions
Pirtobrutinib
Oral Pirtobrutinib
Idelalisib
Oral
Bendamustine
IV
Rituximab
IV
Locations (232)
Southern Cancer Center, P.C.
Daphne, Alabama, United States
Mitchell Cancer Institute -University of South Alabama
Mobile, Alabama, United States
Palo Verde Hematology Oncology
Glendale, Arizona, United States
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, United States
Orange Coast Memorial Medical Center
Fountain Valley, California, United States
California Research Institute
Los Angeles, California, United States
Rocky Mountain Cancer Center
Aurora, Colorado, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Cancer Specialists of North Florida -St Augustine
Jacksonville, Florida, United States
Oncology-Hematology Associates of West Broward
Tamarac, Florida, United States
WellStar Health System
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, United States
Community Health Network
Indianapolis, Indiana, United States
Arnett Cancer Center
Lafayette, Indiana, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Mercy Health-Paducah Medical Oncology and Hematology
Paducah, Kentucky, United States
Cancer Center Office of Clinical Research
New Orleans, Louisiana, United States
Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Ascension St. John Hospital
Grosse Pointe Woods, Michigan, United States
Minnesota Oncology/Hematology PA
Saint Paul, Minnesota, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Nebraska Hematology-Oncology
Lincoln, Nebraska, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Clinical Research Alliance, Inc.
Westbury, New York, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States
Texas Oncology - Amarillo
Amarillo, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
Texas Oncology Fort Worth
Fort Worth, Texas, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Texas Oncology - McAllen
McAllen, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
St Vincent's Hospital
Darlinghurst, New South Wales, Australia
The St. George Hospital
Kogarah, New South Wales, Australia
Ingham Institute of Medical Research
Liverpool, New South Wales, Australia
Westmead Hospital
Wentworthville, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Uniklinikum Salzburg
Salzburg, Osterreich, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria
Medizinische Universität Wien
Vienna, Austria
CHR Verviers-Onco
Verviers, Liege, Belgium
VITAZ
Sint-Niklaas, Oost-Vlaanderen, Belgium
AZ Delta
Roeselare, West Flanders, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Groupe Jolimont
Haine-Saint-Paul, Belgium
AZ St-Elisabeth
Herentals, Belgium
Clinique Saint Pierre Ottignies
Ottignies, Belgium
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Princess Margaret Hospital (Ontario)
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Xicheng District, Beijing Municipality, China
Gansu Province Cancer Hospital
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Hainan Province People's Hospital
Haikou, Hainan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Provincial Taizhou Hospital
Linhai, Zhejiang, China
Beijing Hospital
Beijing, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Blood Institute of the Chinese Academy of Medical science
Tianjin, China
University Hospital Split
Split, Croatia
Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb
Zagreb, Croatia
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
CHU De Grenoble Hopital Albert Michallon
Grenoble, Cedex 09, France
Hospital AVICENNE
Bobigny, Cedex, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Cedex, France
CHD Vendee
La Roche-sur-Yon, La Roche Sur Yon, France
Chu Nimes/Institut De Cancerologie Du Gard
Nîmes, Nimes, France
Pole Regionalde Cancérologie(CHU de Poitiers)
Politiers, Politiers, France
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
Rouen, Seine-Maritime, France
CHRU De Tours
Tours, Tours Cedex 9, France
Centre Hospitalier de la Côte Basque
Bayonne, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, France
CHRU de Brest - Hôpital Morvan
Brest, France
Centre Hospitalier du Mans
Le Mans, France
Hopital Saint Vincent De Paul
Lille, France
Ch Perpignan
Perpignan, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Uniklinik Köln
Kerpener, Köln, Germany
Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik
Langenbeckstraße 1, Mainz, Germany
München Klinik Schwabing
Koelner Platz 1, München, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Lübecker Onkologische Schwerpunktpraxis
Lübeck, Schleswig-Holstein, Germany
Charité Campus Virchow-Klinikum
Berlin, Germany
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, Hungary
University of Pecs 1st. Internalmedicin Clinic Dept
Pécs, Hungary
St James's Hosptial
Dublin, Ireland
Beaumont Hospital, Dublin
Dublin, Ireland
Mater Misericordiae Hospital
Dublin, Ireland
Rabin Medical Center
Petah Tikva, Central District, Israel
Soroka Medical Center
Beersheba, Israel
Laniado Medical Center
Netanya, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Carmel Hospital
Haifa, Ḥeifā, Israel
Irccs Istituto Tumori Giovanni Paolo Ii
Viale Orazio Flacco, Bari, Italy
ASST-Monza -U.O Ematologia Adulti
Monza (MB) -Settore E, Piano 2, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy
Irccs Crob
Rionero in Vulture, Potenza, Italy
AULSS8 Berica-Ospedale S.Bortolo
Vicenza, Veneto, Italy
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, Italy
ASST Spedali Civili - Università degli Studi
Brescia, Italy
A.O.U. Policlinico G.Rodolico - S. Marco
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Ospedale Papardo
Messina, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C
Milan, Italy
A.O.U. di Modena
Modena, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)
Perugia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, Italy
Azienda Ospedaliera Santa Maria Terni
Terni, Italy
A.O.U. Citta' della Salute e della Scienza di Torino
Torino, Italy
Az. Osp. "Card G Panico"
Tricase, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, Italy
Nagoya Medical Center
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Ogaki Municipal Hospital
Ogaki-shi, Gifu, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Tokai University Hospital- Isehara Campus
Isehara, Kanagawa, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
NHO Sendai Medical Center
Sendai, Miyagi, Japan
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-Ku, Tokyo, Japan
JCHO Kyushu Hospital
Fukoka-ken, Japan
Kumamoto University Hospital
Kumamoto, Japan
Okayama University Hospital
Okayama, Japan
Osaka University Hospital
Osaka, Japan
Wojewodzki Szpital Specjalistyczny
Iwaszkiewicza 5, Legnica, Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin, Lublin Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza
Brzozów, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii
Bydgoszcz, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia MCM Krakow
Krakow, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu
Wałbrzych, Poland
Uniwersytecki Szpital Kliniczny Klinika
Wroclaw, Poland
Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"
Omsk, Omsk Oblast, Russia
Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency
Saint Petersburg, Russia
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg, Russia
Oncology Dispensary #2 of Krasnodar Region
Sochi, Russia
Gleneagles Medical Centre
Singapore, Central Singapore, Singapore
Gachon University Gil Hospital
Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea
Pusan National University Hospital
Busan, Pusan-Kwangyǒkshi, South Korea
The Catholic University of Korea-Seoul St. Mary's Hospital
Seocho-Gu, Seoul, South Korea
Seoul National University Hospital
Seoul, Seoul, Korea, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Inje Univ Busan Paik Hospital
Busan, South Korea
Hospital Duran I Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de Toledo
Toledo, Castille-La Mancha, Spain
Complejo Hospitalario Universitario de Santiago de Compostel
Santiago de Compostela, La Coruna, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Planta Baja, Spain
Hospital General de Albacete
Albacete, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Infanta Leonor-INTERNAL MED
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Marques De Valdecilla
Santander, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario de Alava
Vitoria-Gasteiz, Spain
Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale
Bellinzona, Svizzera, Switzerland
China Medical University Hospital
Taichung, Taichung, Taiwan
Tri-Service General Hospital
Taipei City, Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, (r.o.c.), Taiwan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Ankara University Medicine Hospital
Mamak, Ankara, Turkey (Türkiye)
Istanbul University Istanbul Medicine Faculty
Faith, Istanbul, Turkey (Türkiye)
Erciyes University Faculty of Medicine
Kayseri, Melikgazi, Turkey (Türkiye)
Gazi University Faculty of Medicine
Ankara, Yenimahalle, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine
Izmir, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, United Kingdom
The Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Derriford Hospital
Plymouth, Devon, United Kingdom
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom
University College London Hospitals
London, Greater London, United Kingdom
Norfolk and Norwich Hospital
Norwich, Norfolk, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, United Kingdom
St Johns Hospital at Howden
Livingston, West Lothian, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
GenesisCare Cambridge
Newmarket, United Kingdom